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Chemo- and Radiotherapy in Epithelial Vulvar Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer

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Trial Information

Chemo- and Radiotherapy in Epithelial Vulvar Cancer


All patients with primary squamous cell cancer of the vulva > stage Ia who were diagnosed
and received treatment between 1998 and 2008 at the participating centres will be included
in the study. Furthermore patients with recurrent disease diagnosed and treated at the
participating centres during the same time period can be included given that they not only
underwent surgical excision for treatment.

For centers with restricted resources for data entry an alternative study collective was
defined:

All Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or
chemotherapy for treatment at the participating centres between 1998 and 2008 will be
included in the study. This also includes node negative patients receiving
radio/chemotherapy for other reasons.

The participating centers themselves have to decide which study collective they are
documenting, dependent on their available resources.


Inclusion Criteria:



1. Patients with primary squamous cell vulvar cancer except stage Ia disease regardless
of the received treatment

2. Patients with recurrent squamous cell vulvar cancer, if the relapse was not only
treated with a surgical excision.

3. Or alternatively, dependent on the decision of the participating center:

-Patients with primary or relapsed squamous cell vulvar cancer receiving radio-
and/or chemotherapy for treatment regardless of nodal involvement.

4. Patients who were diagnosed with and treated for primary or relapsed vulvar cancer
between 1998 and 2008

5. Women aged ≥ 18 years

Exclusion Criteria:

1. Patients with benign or precursor lesions (VIN - vulvar intraepithelial neoplasia) of
the vulva

2. Patients with non-squamous neoplasia of the vulva (e.g. melanoma)

3. Patients with verrucous vulvar cancer

4. Patients with relapsed squamous cell vulvar cancer only receiving surgical excision
for treatment.

5. Patients with secondary cancers if those interfered with the treatment of vulvar
disease

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Principal Investigator

Sven Mahner, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Center Hamburg-Eppendorf, Department of Gynecology

Authority:

Germany: Ethics Commission

Study ID:

AGO-VOP.1 / CARE

NCT ID:

NCT01304667

Start Date:

February 2011

Completion Date:

June 2012

Related Keywords:

  • Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer
  • Vulvar cancer
  • Radiotherapy
  • Chemotherapy
  • Vulvar Neoplasms

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